The European Commission has published two delegated acts that expand the list of well-established technologies (WET) under the Medical Devices Regulation (MDR) that are exempt from conducting clinical ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Industry and academic stakeholders have asked the US Food and Drug Administration (FDA) to clarify its objectives and plans for a proposed pilot program to evaluate how artificial intelligence (AI) ...
Notified body association Team-NB has suggested changes to the European Commission’s proposals for risk-adaptive surveillance ...
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...
India has adopted legislation expanding the mandatory use of QR codes for tracing more drugs across the supply chain.
A recent report from the US Pharmacopeia (USP) reveals that drug shortages decreased by 23% in 2025; however, the duration of shortages is on the rise. Over 64% of the drugs that are currently in ...
The US Food and Drug Administration (FDA) has revised a 2023 draft guidance on master protocols for drug and biological ...
Officials from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) said that increased ...
The US Food and Drug Administration (FDA) is seeking comments on a pilot program where qualified external institutions will ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focu ...
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